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Investigation details from (b)(6): a review of the barcode scan report, metering report, and column grade was performed via econnectivity by the gtsc.Gtsc was able to recreate the events on the ortho vision using the reports as follows: the column grade report confirmed that sample a was tested on (b)(6)2024 and resulted as b positive.Sample b was tested on (b)(6)2024 and resulted as o positive.Sample a was tested again on (b)(6)2024 and resulted as o positive.The barcode scan report identified that sample a was loaded onto the ortho vision id-mts analyzer on (b)(6)2024 at 09:29am using the handheld scanner and the assign to position function into (b)(6), when the door was closed, the barcode of sample a was read by the internal laser scanner as in (b)(6).An alternate sample id was identified in (b)(6).The barcode scan report also identified that sample a was rescanned on (b)(6)2024 at 09:32am using the handheld scanner and assign to position function into (b)(6).The metering report identified that sample a was pipetted from (b)(6) at 09:30am.Details from the barcode scan and metering reports indicate that the sample was incorrectly scanned into the wrong sample position utilizing the assign to position function on the ortho vision id-mts analyzer.The ortho vision id-mts completed pipetting of the sample as assigned (incorrect location) prior to the operator correcting the assigned placement of sample a.Appears the vision and reagents performed as expected, error appears to be related to user error of assigning sample to incorrect position.Gtsc reviewed the findings with the customer, and they were satisfied with the discussion.As part of the investigation, a review of the manufacturing batch record was requested for mts abd monoclonal and reverse grouping gel card lot 061424037-26, expiration 10may2025.The device history record for the lot was reviewed and no discrepancies were discovered.All in-process and final release serological testing results were within specifications, including customer use ortho vision testing results.All qc inspection records (packaging and gel card inspection documents) of this product lot indicated acceptable results; no gel card defects were identified during qc inspection.All id-mts gel cards used during in-process qc testing passed the visual check performed by the serologist.Formulation stage batch records (anti-a lot 053024039, anti-b lot 053024040) associated with this id-mts gel card lot were reviewed and no discrepancies were discovered.The equipment area use log used during production of this lot was reviewed and no conditions or actions taken were found to directly contribute to this customer complaint.There were no product nonconformances related to this lot.The lot met all specifications, all in-process and product release criteria.(b)(6) testing of retain samples of mts abd monoclonal and reverse grouping gel card lot 061424037-26 was also requested.The lot performed as intended.Mts a/b/d monoclonal and reverse grouping card lot061424037-26 retention cards were tested on the ortho vision analyzer with (b)(4) affirmagen lot8a842, diluent 2 plus lotmdp239, abaq-chek lotv277520 and donor (b)(6).All results were as expected.Product testing with retain cards performed as intended.No discrepant results obtained with albaq-chek and donor sample.A total of (b)(4) retention cards were visually inspected for defects and none were found.Mts a/b/d monoclonal and reverse grouping card lot061424037-26 performed as expected.The manufacturing site was unable to confirm the customer complaint.(b)(6) a query of the worldwide complaint databases was performed for mts abd monoclonal and reverse gel card lot 061424037-26 through (b)(6)2024 for false positive reactions and related failure modes.No complaints have been reported for false positive results or related failure modes for the lot.For thoroughness, a review of the bulk lot, 061424037, was also performed.No additional complaints were identified for any other sublots for false positive results of the b well.No trend was identified by sublot or bulk lot for false positive results of the b well.(b)(6) additionally, as part of the investigation, a review of the manufacturing batch record was requested for (b)(4) affirmagen lot 8a833 expiration 12nov2024.No non-conformances were associated with the lot.(b)(4) affirmagen lot 8a833 met all acceptance criteria.(b)(6) testing of retain samples of (b)(4) affirmagen lot 8a833 was also requested.Manual reverse group test was performed with retain lot 8a833 and mts buffered gel lot 032524004-01 (expiry date 16jan2025), and ten donors: ((b)(6).Results were as expected.The reverse group test was not performed on the vision because the reagent red cell lot was expired, (b)(6)2024.The mts vision instrument is set up to perform testing on in-date reagents.(b)(4) affirmagen lot 8a833 continues to perform as expected and meet release specifications.(b)(6) a query of the worldwide complaint databases was performed for (b)(4) affirmagen lot 8a833 through (b)(6)2024 for false negative reactions of the b cells and related call areas.One additional complaint was identified reported against the red cell reagent lot.Further review of the additional complaint identified in the query found for the instance reported that quality control testing was unaffected and forward and reverse typing for the patient samples were discrepant; therefore, no erroneous results were reported.The lot of mts a/b/d monoclonal and reverse gel cards utilized was not reported.No trend was identified.(b)(6) no further investigation was performed on this incident.The assignable cause was determined to be associated with the operator having manually assigned a sample to an incorrect location using the assign to position function of the vision software.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics reagent or instrument to perform as intended.In mitigation of the user error where the user incorrectly used the assign to position function of the ortho vision software, the reference guide states under the assign to position section: "danger: mismatched samples, reagents, or diluents may result in incorrect results.Remove the appropriate rack from the load station.Enter the sample id, reagent id, or diluent id in the appropriate fields on the screen, as needed.Verify all sample, reagent, or diluent positions are correct through the software screen diagram before starting sample processing." no further complaint of this type has been received from the customer site since the time of the reported event.
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(b)(6)2024, a customer complained to the global technical support center (gtsc) after obtaining what was described as discrepant results for one patient sample for abo forward and reverse group testing on their ortho vision id-mts analyzer (serial (b)(6)) in conjunction with mts abd monoclonal and reverse grouping card lot 061424037-26 and (b)(4) affirmagen lot 8a833.Complainant: (b)(6); medical technologist (b)(6) date of event: 04nov2024, reported (b)(6)2024 equipment: ortho vision id-mts serial: (b)(6) software version: 5.16.0 install date: (b)(6)2020, manufactured: 24aug2020 reagents: mts abd monoclonal and reverse grouping card lot 061424037-26, expiry date: 10may2025 (b)(4) (b)(6) the customer reported that on (b)(6)2024, they had tested one patient sample (sample a) for abo forward and reverse typing using mts abd monoclonal and reverse grouping gel card lot 061424037-26 and (b)(4) affirmagen lot 8a833 in conjunction with their ortho vision id-mts analyzer and that they obtained a b positive result.The customer reported that on (b)(6)2024, they tested a new confirmation sample from the same patient (sample b) for abo forward and reverse typing using mts abd monoclonal and reverse grouping gel card lot 061424037-26 and (b)(4) affirmagen lot 8a833 in conjunction with their ortho vision id-mts analyzer and that they obtained an o positive result.As a result of the discrepant results, on (b)(6)2024, the customer retested sample a on the ortho vision id-mts analyzer in conjunction with the same product lots and that they obtained an o positive result.A biased result was reported to the physician.A corrected report was issued for the affected sample a.The customer reported that the patient was not harmed as a result of this reported event.
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